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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66046

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 01, 2011
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cardiogenesis Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amenable to direct coronary revascularization.

Z-1993-2013
Recall number
Z-1993-2013
Initiated
May 01, 2011
Classification
Class II
Status
Terminated
Recalling firm
Cardiogenesis Corporation
Quantity
2498

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.

Code information

Product Code - HP-SG3 Product Code -HP-PRL5

Distribution pattern

US Distribution